Plymouth Meeting-based Harmony Biosciences received a green light from the Food and Drug Administration to widen the use of Wakix, its flagship narcolepsy drug, writes John George for the Philadelphia Business Journal.
The biopharmaceutical company can now market the sleep disorder drug to pediatric patients who are six and older.
The drug was originally granted marketing clearance by the FDA five years ago as an excessive daytime sleepiness treatment for adult patients with narcolepsy. In 2020, the company got extended approval to market Wakix to patients with cataplexy as well.
The company now plans to talk with the FDA about getting the drug also approved for a cataplexy indication in pediatric patients with narcolepsy, according to Dr. Kumar Budur, the chief medical and scientific officer at Harmony.
“We are very pleased with the Agency’s timely review and approval of Wakix for pediatric narcolepsy patients with excessive daytime sleepiness,” said Dr. Jeffrey M. Dayno, CEO of Harmony.
The FDA ruling also fulfills one of the two requirements needed for pediatric exclusivity, which would extend Harmony’s patent protection on Wakix by another six months to September of 2030 — a significant revenue opportunity for a drug Harmony expects to produce sales of between $700 million and $720 million this year.
The other requirement relates to clinical study data submissions.
Read more about Harmony Biosciences in the Philadelphia Business Journal.
